Effient

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For Patients

Effient (prasugrel) is an antiplatelet drug that prevents the platelets in the bloodstream from aggregating and forming blood clots, used to prevent blood clots in people with acute coronary syndrome who are undergoing a procedure after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels. Side effects of Effient include an increased tendency for bleeding, headache, dizziness, back pain, minor chest pain, tired feeling, nausea, or cough.

Effient treatment is started as a single 60-mg oral loading dose and then continued at 10 mg orally once daily. Patients taking Effient should also take aspirin (75 mg to 325 mg) daily. Effient may interact with NSAIDs (nonsteroidal anti-inflammatory drugs) or warfarin. Tell your doctor all medications and supplements you use. There are no adequate and well-controlled studies of Effient use in pregnant women, although studies in animals did not show any evidence of harm to the developing fetus. Effient should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. It is unknown whether prasugrel is excreted in human milk.

Our Effient Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Safety in patients with ACS undergoing PCI was evaluated
in a clopidogrel-controlled study, TRITON-TIMI 38, in which 6741 patients were
treated with Effient (60-mg loading dose and 10-mg once daily) for a median of
14.5 months (5802 patients were treated for over 6 months; 4136 patients were
treated for more than 1 year). The population treated with Effient was 27 to 96
years of age, 25% female, and 92% Caucasian. All patients in the TRITON-TIMI 38
study were to receive aspirin. The dose of clopidogrel in this study was a
300-mg loading dose and 75-mg once daily.

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials
cannot be directly compared with the rates observed in other clinical trials of
another drug and may not reflect the rates observed in practice.

Drug Discontinuation

The rate of study drug discontinuation because of adverse
reactions was 7.2% for Effient and 6.3% for clopidogrel. Bleeding was the most
common adverse reaction leading to study drug discontinuation for both drugs
(2.5% for Effient and 1.4% for clopidogrel).

Bleeding

Bleeding Unrelated to CABG Surgery - In TRITON-TIMI 38,
overall rates of TIMI Major or Minor bleeding adverse reactions unrelated to
coronary artery bypass graft surgery (CABG) were significantly higher on
Effient than on clopidogrel, as shown in Table 1.

Table 1: Non-CABG-Related Bleedinga(TRITON-TIMI 38)

Effient (%)
(N=6741)

Clopidogrel (%)
(N=6716)

TIMI Major or Minor bleeding

4.5

3.4

TIMI Major bleedingb

2.2

1.7

Life-threatening

1.3

0.8

Fatal

0.3

0.1

Symptomatic intracranial hemorrhage (ICH)

0.3

0.3

Requiring inotropes

0.3

0.1

Requiring surgical intervention

0.3

0.3

Requiring transfusion ( ≥ 4 units)

0.7

0.5

TIMI Minor bleedingb

2.4

1.9

aPatients may be counted in more than one row. bSee for definition.

Figure 1 demonstrates non-CABG
related TIMI Major or Minor bleeding. The bleeding rate is highest initially,
as shown in Figure 1 (inset: Days 0 to 7) [see WARNINGS AND
PRECAUTIONS].

Bleeding by Weight and Age

In TRITON-TIMI 38,
non-CABG-related TIMI Major or Minor bleeding rates in patients with the risk
factors of age ≥ 75 years and weight < 60 kg are shown in Table 2.

Table 2: Bleeding Rates for
Non-CABG-Related Bleeding by Weight and Age (TRITON-TIMI 38)

Major/Minor

Fatal

Effienta (%)

Clopidogrelb (%)

Effienta (%)

Clopidogrelb (%)

Weight < 60 kg (N=308 Effient, N=356 clopidogrel)

10.1

6.5

0.0

0.3

Weight ≥ 60 kg (N=6373 Effient, N=6299 clopidogrel)

4.2

3.3

0.3

0.1

Age < 75 years (N=5850 Effient, N=5822 clopidogrel)

3.8

2.9

0.2

0.1

Age ≥ 75 years (N=891 Effient, N=894 clopidogrel)

9.0

6.9

1.0

0.1

a10-mg Effient maintenance dose b75-mg clopidogrel maintenance dose

Bleeding Related to CABG

In TRITON-TIMI 38, 437 patients
who received a thienopyridine underwent CABG during the course of the study.
The rate of CABG-related TIMI Major or Minor bleeding was 14.1% for the Effient
group and 4.5% in the clopidogrel group (see Table 3). The higher risk for bleeding
adverse reactions in patients treated with Effient persisted up to 7 days from
the most recent dose of study drug.

Malignancies

During TRITON-TIMI 38,
newly-diagnosed malignancies were reported in 1.6% and 1.2% of patients treated
with prasugrel and clopidogrel, respectively. The sites contributing to the
differences were primarily colon and lung. In another Phase 3 clinical study of
ACS patients not undergoing PCI, in which data for malignancies were
prospectively collected, newly-diagnosed malignancies were reported in 1.8%
and 1.7% of patients treated with prasugrel and clopidogrel, respectively. The
site of malignancies was balanced between treatment groups except for
colorectal malignancies. The rates of colorectal malignancies were 0.3%
prasugrel, 0.1% clopidogrel and most were detected during investigation of GI
bleed or anemia. It is unclear if these observations are causally-related, are
the result of increased detection because of bleeding, or are random
occurrences. Other Adverse Events

Table 4: Non-Hemorrhagic Treatment Emergent Adverse
Events Reported by at Least 2.5% of Patients in Either Group

Effient (%) (N=6741)

Clopidogrel (%) (N=6716)

Hypertension

7.5

7.1

Hypercholesterolemia/Hype rlipidemia

7.0

7.4

Headache

5.5

5.3

Back pain

5.0

4.5

Dyspnea

4.9

4.5

Nausea

4.6

4.3

Dizziness

4.1

4.6

Cough

3.9

4.1

Hypotension

3.9

3.8

Fatigue

3.7

4.8

Non-cardiac chest pain

3.1

3.5

Atrial fibrillation

2.9

3.1

Bradycardia

2.9

2.4

Leukopenia ( < 4 x 109 WBC/L)

2.8

3.5

Rash

2.8

2.4

Pyrexia

2.7

2.2

Peripheral edema

2.7

3.0

Pain in extremity

2.6

2.6

Diarrhea

2.3

2.6

Postmarketing Experience

The following adverse reactions have been identified
during post approval use of Effient. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug
exposure.